FDA Label for Aspirin Low Dose
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Aspirin Low Dose Product Label
The following document was submitted to the FDA by the labeler of this product Army And Air Force Exchange Service. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
for the temporary relief of minor aches and pains or as recommended by your doctor
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
hives
facial swelling
shock
asthma (wheezing)
are age 60 or older
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have had stomach ulcers or bleeding problems
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do Not Use
if you are allergic to aspirin or any other pain reliever/fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Ask A Doctor Before Use If
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
you have asthma
you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug for
- gout
- diabetes
- arthritis
Stop Use And Ask A Doctor If
you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor
Other Information
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
Inactive Ingredients
corn starch, dextrates, FD&C yellow #6 aluminum lake, orange enhancer, orange flavor, sodium saccharin
Questions Or Comments?
1-800-426-9391
Principal Display Panel
exchange ✓select™
Compare To The Active Ingredient of Bayer® Chewable Low Dose Aspirin†
81 mg LOW DOSE ASPIRIN
Pain Reliever (NSAID)
•Aspirin Regimen
•Orange flavored
•Chewable
3 BOTTLES INSIDE
36+36+36 Tablets
Actual Size
✓quality value
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
50844 REV0613A21807
"SATISFACTION GUARANTEED OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
1-800-426-9391
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